Hybrid Brain Computer Interface for Control of Sensory - Motor Coupling in Post - Stroke Rehabilitation (HYBIS)

Feasibility Clinical Study of a Novel Hybrid Brain Computer Interface for Control of Sensory-motor Coupling in Post-stroke Rehabilitation

HYBIS project aims to develop an innovative and unique hybrid Brain-Computer Interface (BCI) system. This BCI system is envisioned as a novel tool for targeted reinforcement of sensory motor coupling, specifically dedicated for upper-limb post-stroke rehabilitation.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: BCI feasibility test

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• age over 18 years old at the time of enrolment
• history of cerebrovascular insult verified by computerized tomography or magnetic resonance imaging;
• stoke occurred not more than 6 months prior to study enrolment;
• subject need to be medically and neurologically stable determined by medical history and documented neurological examination;
• ability to understand, communicate and cooperate with the research team;
• ability to sit for at least 45 minutes and the ability to adhere to the study rehabilitation protocol.

Exclusion Criteria:

• any neurologic condition (beyond the stroke) or physical condition that impaired function of the affected arm
• a substantial cardiopulmonary or metabolic disorder or other major medical complication;
• history of seizures;
• moderate to severe hemispatial neglect or anosognosia involving the affected arm;
• severe sensory deficit;
• inability to understand, cooperate, and adhere to the study procedures;
• severe spasticity defined as Ashworth scale score of 4 in the affected arm;
• contraindication to stimulation system placement;
• nursing a child;
• pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stroke patients; Experimental group of stroke survivors for testing the feasibility of a BCI system	Device: BCI feasibility test; Testing the feasibility of BCI device by determining the accuracy of BCI control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrotactile BCI system accuracy	Electrotactile BCI system accuracy is a measure of feasibility of the prototype device. Accuracy [0 -100 %] of classification of user's mental strategy (tactile attention task towards one of the two electrical stimulation hotspots), where higher values of accuracy are related to better system control.	within 30 minutes after experimental session
Motor Imagery BCI system accuracy	Motor Imagery BCI system accuracy is a measure of feasibility of the prototype device. Accuracy [0 - 100 %] of classification between rest and imaginary movement in a cue-based manner, , where higher values of accuracy are related to better system control.	within 30 minutes after experimental session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl Meyer sensory score for upper extremity	Fugl Meyer sensory score for upper extremity assesses the degree of sensory impairment in the upper arm. Sensation score ranges from 0 to 12 points, divided into 4 points for light touch and 12 points for position sense. Individual items pertaining to the light touch sensation of the upper arm/ forearm and palmary surface of the hand and to the position of the shoulder/ elbow/ wrist/ thumb (IP-joint) are scored on a 3-point ordinal scale and summed for a maximum possible score of 12. The higher score is considered to represent a less sensory deficit of the subject	immediately after experimental session
NASA-TLX	NASA Task Load Index (NASA-TLX) method assesses workload on six scales for different aspects: mental demand, physical demand, temporal demand, performance, effort, and frustration on a 21-point scale. A higher rating represents higher workload.	within 30 minutes after experimental session

Collaborators and Investigators

• Sponsor: University of Belgrade

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: November 13, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 6066223

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No